Responsible Person (MHRA)

Location: Crewe 

Pay Rate: £13 per hour 

Shift: Monday - Friday, 07:00 - 16:00 (with a 30-minute break)

Are you a highly organised and experienced professional with a strong background in pharmaceutical compliance? The Amethyst Group is looking for a Responsible Person (RP) to ensure our operations meet all regulatory standards. You'll be the key contact for all things related to Good Distribution Practice (GDP) and the primary liaison with the MHRA (Medicines and Healthcare products Regulatory Agency).

What You'll Do:

• Maintain and update the Quality System to comply with all EU Directives, Regulations, and MHRA Guidelines on GDP.
• Oversee all operations involving medicinal products, from sourcing and receipt to storage and final customer delivery, ensuring full traceability.
• Ensure our premises and equipment meet current GDP requirements.
• Approve new pharmaceutical customers and verify the bona fides of all suppliers and customers.
• Manage product returns, recalls, and quarantined stock, making and recording all necessary decisions.
• Keep all staff training records up to date and ensure staff are properly trained on all Standard Operating Procedures (SOPs) and GDP best practices.
• Conduct annual mock recalls to test the robustness of our recall procedures.
• Serve as the company's lead for all Health & Safety matters, including reviewing risk assessments and reporting accidents.

What We're Looking For:

• Proven experience as a Responsible Person with a comprehensive knowledge of business operations under the Wholesale Authorisation (WA).
• Expertise in GDP compliance and the ability to stay updated on all legal and regulatory developments.
• Strong attention to detail and a proactive approach to ensuring all records are completed and maintained accurately.
• Excellent communication skills to liaise with internal teams, customers, and the MHRA.

IOSH Health & Safety qualified.

If you are a diligent professional with a commitment to quality and compliance, we encourage you to apply and become a vital part of our team!